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Director, Clinical Pharmacology & Quantitative Pharmacology (CPQP)

Местоположение Royston, Англия, Великобритания Гейтерсберг, Мэриленд, США Уолтем, Массачусетс, США Идентификатор вакансии R-092161 Дата публикации 10/26/2020

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing.

Want to be part of an exciting team doing ground-breaking work? Then this opportunity could be for you!

This is a line management role which also includes project accountabilities, as well as responsibilities to lead initiatives related to scientific, strategic and/or improvement initiatives, either at therapy area (TA), functional or cross-functional levels. The individual will lead a team of Clinical Pharmacologists (CP) and Clinical Pharmacometricians (PMx) and will be responsible for recruitment, retainment, and development of staff to establish a dynamic and science-focussed team. You will report to the TA Head, act as their delegate where necessary, and work closely with members of the TA CPQP leadership team and organisation to ensure consistent and valued CPQP contributions across the TA portfolio.

The TA Group Director will also have project accountabilities and work closely with clinical teams to ensure state-of-the-art Clinical Pharmacology and Model-Informed Drug Development (MIDD) approaches are implemented to influence designs and internal/external decision making. The individual will also lead or support local/global initiatives in areas related to science, portfolio, harmonization etc.

Key Responsibilities:

  • Lead a team of CP and PMx scientists delivering quality clinical pharmacology input to projects from pre-CDID to life-cycle management (LCM)
  • In close collaboration with the CPQP TA Head and other CPQP line managers be accountable for resource management, providing flexible, competent and responsive service with appropriate quality and speed according to business needs; continuously enhance productivity and cost efficiency where relevant

  • Support the TA Head in development of strategy, in scientific operations and business management

  • Act as delegate for the TA Head at functional LT meetings, Clin Pharm review Board, governance, and other TA interactions, as necessary

  • Act as project Clinical Pharmacologist as required leading development and implementation of the clinical pharmacology strategy

  • Leads all aspects of communication with multiple partners both within and external to the organization, often influencing key decisions.

  • Contribute to ensure a positive collaborative culture and dialogue with key partner functions such as Early and Late TA clinical organisations, Biostatistics, DMPK and Biosciences, Translational medicine, Pharmaceutical Sciences and Regulatory affairs

  • Scientific and strategic input into pre-clinical, clinical, and post-approval development plans across the TA

  • With the TA director PMx accountable for oversight, support and delivery of scientific and strategic modeling work related across the TA in both early and late development

  • Support and review evaluation of candidates for in/out-licensing

  • Contribute and lead within and cross-TA peer review

  • Provide mentoring within and across TA’s

  • Support and contribute to the learning development for the TA providing training and knowledge sharing

  • Monitoring external and internal environment in terms of relevant new methodologies and applications

  • Increase AZ profile externally in the area of CPQP by speaking at external events, by publication in recognized external journals and representing CPQP at strategic cross-industry and academic initiative and consortia as necessary

  • Ensure CPQP contributions for the TA are aligned with current regulations and stays in sync with the principles of GCP and GxP.

Essential

  • Demonstrated broad translational and clinical development experience exemplified by a proven track record of international drug development or equivalent experience (early and late clinical)

  • Can develop people, drives performance, holds self and others accountable

  • Record of building successful internal/external partnership and collaboration relationships, demonstrating cultural sensitivity and awareness

  • Experience of leading teams

  • Strong leadership capabilities including influencing skills

  • Experience in mentoring and developing others

  • Conceptual, analytical and critical thinking

  • International scientific reputation gained from scientific publishing in the field of quantitative clinical pharmacology

  • Demonstrated ability to identify, develop and execute strategic CPQP activities

  • Relevant TA disease domain knowledge

  • Relevant regulatory experience (written/oral)

  • A demonstrated knowledge of regulatory, compliance, processes, standards and issues specific to CPQP

  • PhD degree preferred or equivalent (M.Sc./Pharm.D.) with relevant experience required

Desirable

  • Experience in several global pharmaceutical organisations

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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